Trial Database Activities for Simplified Treatment for the Prevention of Eclampsia with Magnesium Sulfate (STEP-Mag): A Phase III, Multinational, Randomized, Open-Label, Active-Controlled, Non-Inferiority Trial
2022 - 2023
Period: 2022 – 2023
Researchers:
- Dr. Mabel Berrueta
- Dr. Luz Gibbons
- Lic. Rocío Rodriguez
- Bioq. Sara Reidel
- Lic. Franco Scarafia
- Lic. Álvaro Ciganda
- Lic. Juan José Quispe
Objective: Joint collaboration study between the Statistics, Data Management and Information Systems Unit and the IECS Maternal and Child Health Research Department. Phase 3 clinical trial, multi-country, multicenter, two arms, parallel, open, with control arm, randomized and non-inferiority. Its main objective is to evaluate the non-inferiority of a single magnesium sulfate regimen compared to 2 standard regimens (Zuspan or Pritchard) for the prevention of maternal eclamptic seizures.
Type of study: Clinical trial.
Finance: WHO extension.